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Range Spinal System (Mesa and Denali)

by K2M, Inc. 4 variants

510(k) K120099

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120099 Date18 May 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MNI
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Range Spinal System (Mesa and Denali) is a spinal fixation device classified as a non-cervical pedicle screw fixation system. It is designed for posterior stabilization as an adjunct to spinal fusion, providing structural support in cases of trauma such as fractures or dislocations.

This system is supplied as a reusable medical device and is intended for use in orthopedic surgical settings. It is cleared under FDA 510(k) with the product code MNI, and the components include the Denali Deformity System, Mesa Spinal System, and ARI Anterior Vertebral Body Staples. Sterility and MRI safety specifications are not explicitly stated in the provided data.

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